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FDA Operations Chief Announces Retirement

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FDA deputy commissioner for operations and chief operating officer Barclay Butler announces his retirement in the coming months.

Attorneys Review FDAs New Inspection Approach for Devices

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Ropes & Gray attorneys Joshua Oyster and Austin Laroche review in a WestLaw Today article FDAs new inspection approach for medical...

Regulate Outsourcing Ophthalmic Bevacizumab Products: Petition

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A Buchanan petition asks FDA to take administrative and enforcement action against 503B outsourcing facilities that are marketing ...

Senate Committee Has More Drug Supply Questions

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Bipartisan leaders of the Senate Select Committee on Aging ask CVS, Walgreens, and Walmart for additional information on their eff...

FDA Official Pushes Back in UniQure Dispute

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A senior FDA official sharply criticizes UniQures investigational gene therapy for Huntington's disease, calling it a failed produ...

FDA Approves Teclistamab Combination for Multiple Myeloma

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FDA approves Janssen Biotechs Tecvayli (teclistamab) in combination with Darzalex Faspro (daratumumab hyaluronidase-fihj) for cert...

ExThera Regulatory Chief Charged With Concealing Adverse Events

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The U.S. Department of Justice charges the former chief regulatory officer at ExThera Medical Corp. with concealing serious advers...

Breakthrough Status for Hemabs Bleeding Disorder Therapy

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FDA grants Hemab Therapeutics a breakthrough therapy designation for sutacimig, an experimental therapy being developed to prevent...

Petition Asks FDA to Investigate Mayo Robotic Mastectomy

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Harmed Americans for Reform in Medical Device Safety petitions FDA to investigate the Mayo Clinics use of a robotic mastectomy dev...

Rep. Auchincloss Criticizes Commissioners Priority Voucher Program

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Rep. Jake Auchincloss (D-MA) criticizes FDAs new voucher program that offers select drugmakers sharply shortened review timelines,...